RESCHEDULED: The presentation previously scheduled for Thursday, March 28th, Session 3 – Consent/Assent for Minor Subjects and Cognitively Impaired Adult Subjects has been rescheduled for Thursday, May 23rd.

Additional consideration is necessary for enrollment of subjects who cannot consent for themselves; minors and cognitively impaired adults.  This session will cover the requirements for obtaining informed consent from a Parent/Guardian or Legally Authorized Representative (LAR) as well as best practices for obtaining and documenting assent from subjects.
Other topics to be addressed include:

  • Assessing capacity to consent
  • Who has legal authority to provide informed consent for subjects who are not able to consent for themselves
  • Procedures for obtaining consent when/if capacity to consent changes